Medical Director

Role Summary

The Medical Director leads Sarepta’s clinical-stage programs, defines strategic priorities for the program, and integrates cross-functional input to develop and execute the clinical development plan. They represent clinical development on the clinical study team, driving program development, approval, and commercialization, and lead a team with deep knowledge of the clinical drug development process from early/translational phases through registration.

Responsibilities

• Function as the clinical development leader to create and execute a clinical development plan that provides strategic priorities and solutions to program challenges.
• Partner with cross-functional leaders and governance bodies to provide leadership and direction to support the clinical development plan and drive cross-functional decision making.
• Establish and maintaining positive relationships with clinical trial investigators/physicians, KOLs, and clinical advisors through independent collaborations and scientific meetings.
• Provide expertise and leadership to support protocol development, regulatory agency engagements, and documents including INDs and NDAs.
• Provide clinical oversight and medical monitoring for clinical trials; ensuring patient safety, protocol adherence, data quality and integrity, and compliance with ICH/GCP and regulatory requirements.
• Analyze, interpret, and contextualize clinical trial data to support program-level decision making.

Qualifications

• MD or PhD required; subspecialty training in neurology preferred.
• 6-8+ years of hands-on pharmaceutical or biotech experience in clinical development; rare/orphan diseases preferred, but not required.
• Prior IND/CTA and/or NDA/MAA filing experience.
• In-depth knowledge of the drug development process and oversight of clinical trials.
• Working knowledge of biostatistics, regulatory, clinical pharmacology, and pharmacokinetics.
• Excellent interpersonal, written, verbal, and visual communication skills.
• Proven ability to successfully manage multiple tasks and priorities; strong cross-functional collaboration and presentation skills.
• Willingness to travel.
• Ability to work collaboratively in a fast-paced, team-based matrix environment.
• Intellectual curiosity, flexibility, drive, and resilience.

Education

• MD or PhD required; subspecialty training in neurology preferred.